BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX CPA SOLUTION

    MDR report key: 907880 · Received September 6, 2007

    Report

    Report Number
    2084725-2007-00256
    Event Type
    Injury
    Date Received
    September 6, 2007
    Date of Event
    August 8, 2007
    Report Date
    August 8, 2007
    Manufacturer
    JOHNSON & JOHNSON
    Product Code
    LRJ
    PMA / PMN Number
    K991487
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CALLED ASKING ABOUT THE EFFECTS OF USING CIDEX OPA WHILE PREGNANT, SHE STATED THAT WHILE PREVIOUSLY WORKING WITH CIDEX SHE WAS GRAVIDA 3 PARA 3. SINCE HER FACILITY CHANGED TO CIDEX OPA SHE STATED THAT SHE HAS HAD ONE MISCARRIAGE AND IS THREATENING TO HAVE ANOTHER. THE CUSTOMER STATED THAT SHE ALSO EXPERIENCES "LIGHT HEADEDNESS" AND A "RESPIRATORY ISSUE" OCCASIONALLY WHEN WORKING WITH CIDEX OPA. ATTEMPTED TO CONTACT THE CUSTOMER TO GET MORE INFORMATION REGARDING HER SYMPTOMS AND POSSIBLE TREATMENT RECEIVED, BUT THE CUSTOMER WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX CPA SOLUTION DISINFECTANT LRJ JOHNSON & JOHNSON 20390 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR